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Compliance Manager, Quality Assurance

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

In-depth knowledge of GxP compliance, Experience in regulatory inspections, Expertise in Parexel procedures, Ability to lead audit programs, Strong decision-making skills.

Key responsabilities:

  • Host and support Sponsor audits
  • Manage and implement assigned audits
  • Advise on remediation activities
  • Coordinate QA compliance activities
  • Oversee preparation for inspections
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Parexel Pharmaceuticals XLarge http://www.parexel.com/
10001 Employees
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Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Have in-depth knowledge and experience of appropriate GxP compliance and other applicable regulations and laws; Parexel procedures and appropriate Parexel processes, to host and support Sponsor audits and Regulatory inspections; and provide expert advice to internal and external clients. To effectively lead, matrix-manage, develop, and implement assigned audits and Inspections. They have the authority and decision-making responsibility to drive Parexel departments’ and Project teams’ Sponsor Audit and Regulatory Inspection preparation activities, and to advise on remediations as needed. To exhibit a high degree of flexibility and initiative; demonstrate the ability to follow up on multiple tasks and projects.
The Compliance Manager will have a relevant role in the management/coordination/oversight of QA compliance GxP activities in a specific geographical and/or functional/specialist area as required. They may also act as QA leads for audit programs.

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Decision Making
  • Leadership
  • Verbal Communication Skills
  • Physical Flexibility

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